Distribution, Manufacturing and Inspection

Notice on recall of Ramipril H Farmal 5 mg/25mg tablets (ramipril, hydrochlorothiazide)


Farmal d.d., the marketing authorisation holder for Ramipril H Farmal 5 mg/25 mg tablets (ramipril, hydrochlorothiazide) has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch 140802 of this medicine due to a discovered quality defect. The quality defect relates to the labelling on the aluminium foil on blisters in Ramipril H Farmal 5 mg/25 mg tablets, where there is an incorrect product name Ramipril Farmal 5 mg tablets (ramipril) instead of Ramipril H farmal 5mg/25 mg tablets (ramipril, hydrochlorothiazide).

It is a pharmacy level recall.

There are other medicinal products with the same active substance combination available on the Croatian market that are not affected by this quality defect. It is expected that this recall will cause no shortage of this medicine.

No reports of suspected quality defects of Ramipril H Farmal 5mg/25 mg tablets have been received by HALMED. HALMED will continue to monitor from the close the safe use of this medicine and will promptly make publically available any new information.

We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.